FDA product code HPF: Aid, Vision, Electronic, Ac-Powered
HPF is the FDA product code for aid, vision, electronic, ac-powered. It is a Class I device, regulated under 21 CFR 886.5900 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HPF. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Aid, Vision, Electronic, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.5900 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPF clearance
Top HPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sensory Aids Corp. | 1 | 1986-10-31 |
Most recent HPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863993 | Sensory Aids Corp. | VTS REPORTER OR VTS LINK | 1986-10-31 | 17 |
Recalls for HPF devices
openFDA lists no recalls for product code HPF.
Frequently asked questions
What is FDA product code HPF?
HPF is the FDA product code for aid, vision, electronic, ac-powered. It is a Class I device, regulated under 21 CFR 886.5900 and reviewed by the Ophthalmic panel.
What device class is HPF?
Class I, regulation 21 CFR 886.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPF?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most HPF clearances?
Sensory Aids Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPF
- Run a recall and safety report across every HPF manufacturer
- Watch product code HPF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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